UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057743 |
|---|---|
| Receipt number | R000065986 |
| Scientific Title | Retrospective study of pulmonary hypertension associated with progressive pulmonary fibrosis |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/04/30 14:08:23 |
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Basic information
Public title
Retrospective study of pulmonary hypertension associated with progressive pulmonary fibrosis
Acronym
Retrospective study of pulmonary hypertension associated with progressive pulmonary fibrosis
Scientific Title
Retrospective study of pulmonary hypertension associated with progressive pulmonary fibrosis
Scientific Title:Acronym
Retrospective study of pulmonary hypertension associated with progressive pulmonary fibrosis
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pulmonary hypertension associated with interstitial pneumonia has been thought to have a negative prognostic impact. In recent years, novel therapies for this condition have been developed and have attracted much attention. However, most previous studies have focused on idiopathic pulmonary fibrosis (IPF) among interstitial pneumonias. Very few studies have focused on non-IPF.
The purpose of this study was to investigate the association between interstitial pneumonia with progressive pulmonary fibrosis (PPF) and pulmonary hypertension. It is highly significant to investigate the number of potential patients at a time when new treatment methods are being established.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of pulmonary hypertension in PPF
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet all of the following 1)~3)
1) Age 18 years or older
2) Those who have been diagnosed with interstitial pneumonia
3) Who have undergone echocardiography or right heart catheterization at the Department of Respirology, Chiba University Hospital between January 1, 2017 and December 31, 2021.
Key exclusion criteria
Those who meet any of the following criteria
1) Those whose onset of pulmonary hypertension preceded the diagnosis of interstitial pneumonia
2) Patients who have undergone lung transplantation
3) Those who have expressed their refusal to participate in this study through the information disclosure document.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Takeda |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-Ku, Chiba
TEL
0432227171
kenichiro.1990.0909@gmail.com
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Takeda |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-Ku, Chiba
TEL
0432227171
Homepage URL
kenichiro.1990.0909@gmail.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Observational Research Ethics Committee of Chiba University Hospital
Address
1-8-1 Inohana, Chuo-Ku, Chiba
Tel
0432227171
hsp-kansaturinri@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
139
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prevalence and survival will were observed retrospectivelye
Management information
Registered date
| 2025 | Year | 04 | Month | 30 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065986
